Dan-Li Tian, Gen-Li Han, Yan-Shuang Feng, Hai-Xia Ren, Xiao-Dan Li, Liang Zhang, Xiao-Chen Wei
Omadacycline was effective and safe for CAP treatment in real-world practice, including elderly and comorbid patients.
OBJECTIVES: While randomized controlled trials demonstrate omadacycline's efficacy and safety in community-acquired pneumonia (CAP), real-world evidence is sparse. This study evaluated clinical effectiveness, safety, and the factors influencing clinical success and 30-day mortality for CAP patients treated with omadacycline in real-world conditions.
METHODS: We performed a study of CAP patients treated with omadacycline. The outcomes included clinical efficacy, 30-day mortality, microbial eradication, and adverse events. Multivariate logistic regression identified risk factors for clinical failure, with model performance assessed by Receiver Operating Characteristic (ROC) curves. Kaplan-Meier survival analysis and Cox proportional hazards regression were used to analyze prognostic factors.
RESULTS: Among 150 patients, the clinical success rate was 86.0%. Multivariate analysis identified respiratory failure (OR 10.817, 95% CI 1.800-64.990) and higher Pneumonia Severity Index (PSI) score (OR 1.028, 95% CI 1.006-1.051) as independent risk factors for clinical failure. The ROC curve showed the area under the curve (AUC) value of the prediction model was 0.946 (95% CI: 0.904-0.989). The 30-day mortality rate was 6.7%. Kaplan-Meier analysis showed poorer survival for patients with Sequential Organ Failure Assessment (SOFA) score ≥2, PSI >130, age >80 years, ICU admission, or early clinical failure (P < 0.05). Cox regression confirmed early clinical failure (HR 0.031, 95% CI 0.001-0.710) and higher SOFA score (HR 1.500, 95% CI 1.076-2.091) independently predicted 30-day mortality.
CONCLUSION: Omadacycline was effective and safe for CAP treatment in real-world practice, including elderly and comorbid patients.